Opioid Manufacturer Endo Health Solutions Inc. Ordered to Pay $1.536B In Criminal Fines

EHSI pleaded guilty on April 18 to one misdemeanor count of introducing misbranded drugs into interstate commerce. In pleading guilty, EHSI admitted that from April 2012 through May 2013, certain EHSI sales representatives marketed Opana ER to prescribers by touting the drug’s purported abuse deterrence, tamper resistance and/or crush resistance, despite a lack of clinical data supporting those claims.

EHSI’s corporate affiliates emerged from bankruptcy on April 23. EHSI will cease to operate in its current form and will not emerge from bankruptcy. Payment of the criminal fine imposed at sentencing is addressed as a component of the broader resolution resolving all monetary claims held by the United States against the corporate entities.

In addition, as part of the confirmed bankruptcy plan, the new company has funded voluntary trusts in settlement of opioid-relating claims, including public trusts that will pay over $450 million to state, municipal and Tribal entities to help fund programs to abate the opioid crisis. 

The department is crediting up to $450 million of such payments against the agreed forfeiture amount. The EHSI affiliates that have emerged from bankruptcy are subject to an injunction restraining future opioid sales and marketing and requiring the publication of millions of documents relating to its role in the opioid crisis.

In pleading guilty, EHSI admitted that certain sales managers were aware that the sales representatives were making claims of purported abuse deterrence, tamper resistance and/or crush resistance when marketing Opana ER to prescribers, and that certain sales representatives were striking non-medicated sample pills with hammers and conducting other demonstrations to convey the message that Opana ER was, in fact, crush proof and tamper resistant. The approved labeling for Opana ER did not provide adequate information for healthcare providers to safely prescribe Opana ER for use as an opioid that is abuse deterrent.

According to the plea agreement, EHSI was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the FDCA.

EHSI withdrew Opana ER from the market in 2017.